STATISTICAL AND CLINICAL COORDINATING CENTER, AUTOIMMUNE DISEASE CLINICAL

Rho Federal Systems Division, Inc., Chapel Hill NC

Investigators

Abstract

The Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials provides complete biostatistical and operational support for clinical trials in the area of autoimmune diseases. Studies currently being supported include multiple autoimmune disease clinical protocols sponsored by the Autoimmunity Centers of Excellence, as well as autologous stem cell transplantation for autoimmune disease. Support for these and other studies in autoimmunity will include: 1) statistical leadership for the design and analysis of clinical trials, including periodic safety and administrative reports, Data Safety Monitoring Board reports and final analyses; 2) clinical site monitoring and training; 3) data collection, management and quality assurance programs; 4) regulatory support for IND and associated regulatory submissions, including serious adverse event data collection, evaluation and report preparation; 5) distribution and quality control of study products; and 6) support for technical and administrative functions of the clinical trial consortiums.